Subjects in a study receiving standard of care (SoC) complemented with Sky Medical Technology’s wearable device reported accelerated wound healing in hard-to-heal venous leg ulcers (VLUs).
The London, UK-based company’s self-adhesive device, called ‘geko’, is a wearable neuromuscular electrostimulator that delivers a gentle electrical pulse in the leg to stimulate blood flow. The device received FDA clearance for improving microcirculatory blood flow in lower limb ischemic tissue in 2021.
The study, published in the International Wound Journal, is the first RCT to show a statistically significant increase in the rate of healing of VLUs treated with an advanced neuromuscular electrostimulation device combined with multi-layer compression.
“The market that has seen surprisingly little real innovation in SoC over 20 years. Gold standard multi-layer compression can be effective, particularly in less complex and smaller wounds, but even in these patients is too often associated with low patient adherence,” said Bernard Ross, founder and CEO of Sky Medical Technology.
The most treated wounds in the UK are leg ulcers – chronic wounds that occur in the lower leg. According to the NHS, 1.5% of UK wound patients are estimated to have a leg ulcer. The annual cost of managing wounds in the NHS is £5.3bn and, according to Sky Medical Technology, £2bn of this is spent on venous leg ulcers – the most common type of leg ulcer.
“As a clinician in wound care, especially when managing patients with chronic wounds, the ultimate goal is improvement in healing rates,” said tissue viability specialist nurse lead, Agnes Juguilon Collarte.
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By GlobalDataThe results of this randomised self-controlled trial are extremely impressive and are also borne out in our direct experience of real-world use. The geko device consistently accelerates VLU healing in the patients I treat.”
The venous leg ulcer market is expected to reach $4.84bn by 2026 growing at a CAGR of 6.4%. Innovations in compression technology as well as devices are driving the market. Sigvaris already have a range of ulcer compression kits at market.